Imaging-based Prediction of Stent-free Pharmaco-mechanical Thrombolysis in Patients With Extensive Acute Ilio-femoral Deep Vein Thrombosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- During the procedure
研究概览
简要总结
This prospective single-arm cohort study aims to develop an AI-powered prediction model for treatment outcomes in patients with acute extensive iliofemoral deep vein thrombosis (IF-DVT) undergoing stent-free pharmacomechanical thrombolysis. The study addresses the current lack of validated tools for patient selection and outcome prediction in catheter-directed interventions for proximal DVT.
Thirty consecutive adult patients with MRV-confirmed acute IF-DVT will undergo pharmacomechanical thrombolysis using the AngioJet ZelanteDVT system with adjunctive rtPA administration.
The primary objective is to develop a convolutional neural network (CNN) trained on serial MRV imaging data to predict three-month venous recanalization success. MRV acquisitions occur at baseline, predischarge, and three-month follow-up. Ground truth segmentation will be performed by an experienced radiologist using 3D Slicer, with semi-automated propagation across the dataset. Feature extraction will include geometric metrics, radiomic texture analysis, and morphological characteristics of both thrombus and vessel architecture.
Secondary endpoints include acute kidney injury incidence (a significant concern with rheolytic thrombectomy due to hemolysis-induced nephrotoxicity), post-thrombotic syndrome development assessed via Villalta scoring, and various safety outcomes including major bleeding per ISTH criteria.
The study protocol incorporates rigorous monitoring for AKI using KDIGO criteria, with systematic evaluation of renal function, hemolysis markers, and electrolyte balance. Hydration protocols and nephroprotective measures will be standardized, though specific strategies require clarification from the nephrology team.
This research addresses critical gaps in evidence-based patient selection for invasive DVT treatment, particularly following the mixed results of the ATTRACT trial. The AI prediction model could enable personalized treatment decisions, potentially improving the risk-benefit ratio of pharmacomechanical interventions while reducing unnecessary procedures in patients unlikely to benefit.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive adult (≥18 years) patients with an MRV-based diagnosis of acute IF- DVT
- •Symptomatic patients with severe pain and\or leg swelling more than 5 cm
- •Willing to participate in the study
排除标准
- •Previous history of VTE
- •Presence of DVT syndrome for more than 21 days
- •Terminal systemic disease requiring palliative treatment
- •Active bleeding
- •History of hemorrhagic stroke
- •Major fibrinolytic contraindication
- •Any hereditary coagulopathy disorders
- •Patients with baseline renal dysfunction with an estimated glomerular filtration rate (eGFR) of < 60 ml/min/1.73m2 due to Cockroft-Gault formula based on the creatinine level at the time of admission
- •Having any underlying condition that makes the patient unsuitable for MRV and/or rheolytic thrombectomy procedure (e.g., allergy to contrast agent, claustrophobia)
- •Having any underlying disabling condition that necessitates a prolonged complete bed rest prohibiting early ambulation
- •Low-quality MRV imaging or motion artifact (exclusion criteria for the imaging sub-studies)
结局指标
主要结局
During the procedure
时间窗: 3 months post-procedure
The extent of venous recanalization after stent-free pharmacomechanical thrombolysis as assessed by magnetic resonance venography at three months post-procedure. Recanalization will be graded as: Grade 0 (no flow/complete occlusion), Grade 1 (minimal flow with ≤25% lumen patency), Grade 2 (partial flow with 26-75% patency), or Grade 3 (near-complete flow with \>75% patency). Treatment success is defined as achieving Grade 2 or 3 recanalization.
次要结局
- Postprocedural Gross Hematuria(During index hospitalization (typically 3-7 days))
- MRV-based Predischarge Venous Recanalization(At hospital discharge (typically 3-7 days post-procedure))
- At hospital discharge (typically 3-7 days post-procedure)(3 months post-procedure)
- MRV-based Predischarge Percentage Reduction in Thrombus Volume(At hospital discharge (typically 3-7 days post-procedure))
- Postprocedural Acute Kidney Injury Occurrence(During index hospitalization (typically 3-7 days))
- Need for New Renal Replacement Therapy(During index hospitalization (typically 3-7 days))
- Postprocedural Oliguria or Anuria(During index hospitalization (typically 3-7 days))
- Postprocedural Hyperkalemia(During index hospitalization (typically 3-7 days))
- Major Bleeding Events(During index hospitalization (typically 3-7 days))
- Three-month Recurrent Venous Thromboembolism(3 months post-procedure)
- In-hospital All-cause Mortality(During index hospitalization (typically 3-7 days))
- Three-month All-cause Mortality(3 months post-procedure)
- Three-month Post-thrombotic Syndrome Incidence(3 months post-procedure)
- Three-month Post-thrombotic Syndrome Severity(3 months post-procedure)
- Technical Success Rate(During the procedure)
研究者
Parham Sadeghipour
Doctor
Rajaie Cardiovascular Medical and Research Center